Preparing Consent and Authorization Documents When Relying on an External IRB Review

Version: March 2019

When study teams rely on an external IRB for studies that will enroll subjects at UW-Madison or UW Health and written informed consent will be required, they will need to prepare consent and, if applicable, authorization documents that include institutionally required language. This document describes how to prepare these consent and authorization documents, which should be submitted with any request to cede IRB review to an external IRB. 

Instructions for Preparing Consent Documents

  1. Please start with the model consent template, which should be provided by the lead study team. If you have not received a consent template, please contact the lead study team and ask them to provide the template to you. For multi-site studies where no consent template was provided, use the Health Sciences IRBs consent templates found here.
  2. Adjust the lead site consent template using track changes to include site specific information and UW-Madison institutional language as described below. Submit the proposed consent with the Request to Cede IRB Review to an External IRB in ARROW. For an overview of the roles related to preparing consent documents when relying on an external IRB, see the SMART IRB Guidance on Inserting “Local Context” Language in Informed Consent Documents.
  3. When reviewing requests to cede IRB review, the HS IRBs Reliance Team will review the documents to ensure the required consent elements and any institutionally required language have been included.
  4. NOTE: This same process can be followed for preparing assent documents. Generally, UW-Madison can accept the assent process approved by the reviewing IRB. In Wisconsin, the age of majority for most treatments or procedures is 18 years of age. For questions about state law, please see Issues in Human Subjects Research When State Law May Apply.

Short and Concise Summary

Risks and Discomforts

Confidentiality and Authorization

Compensation for Injury

Mandatory Reporting

Conflict of Interest Language

Additional Language

Instructions for Preparing Authorization Documents:

  1. As with the consent document, the lead study team will typically provide relying study teams with an authorization template or combined consent and authorization template. The HS IRBs will accept either format. In the event the lead study team and/or reviewing IRB does not provide a template authorization document, the UW-Madison templates should be used.
  2. The Reliance Team will review the authorization language to determine whether the required elements are present, but no other institutionally-required language is typically needed.